Valproate in Dementia (VALID)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

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Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Valproate

250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout

Placebo

Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Valproate

250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout

Placebo

Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout

Total

Total of all reporting groups

Baseline Measures

Valproate

Placebo

Total

Overall Participants Analyzed [Units: Participants]

153

160

313

Age [Units: Years]Mean (Standard Deviation)

74.9 (8.2)

76.6 (7.4)

75.7 (7.8)

Gender [Units: Participants]

Female

83

101

184

Male

70

59

129

Region of Enrollment [Units: Participants]

United States

153

160

313

ADAScog [1] [Units: Units on a scale]Mean (Standard Deviation)

29.4 (8.9)

30.1 (9.8)

29.8 (9.4)

[1]

Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.

ADCS-ADL [1] [Units: Units on a scale]Mean (Standard Deviation)

56.9 (11.8)

54.9 (13)

55.9 (12.4)

[1]

Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.

CDR-SOB [1] [Units: Units on a scale]Mean (Standard Deviation)

7.1 (2.7)

7.5 (3.1)

7.3 (2.9)

[1]

Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.

CMAI [1] [Units: Units on a scale]Mean (Standard Deviation)

10.9 (8.9)

11.9 (10.4)

11.4 (9.7)

[1]

The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.

NPI [1] [Units: Units on a scale]Mean (Standard Deviation)

2.6 (2.6)

3.1 (2.6)

2.9 (2.6)

[1]

The Neuropsychiatric Inventory (NPI) quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, sleep change, appetite change, and others. This is a structured questionnaire administered to the subject's caregiver/study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment.

Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician [ Time Frame: 24 months ]

250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout

Placebo

Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout